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Peripheral Interfaces in Amputees for Sensorimotor Integration (iSens)

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VA Office of Research and Development

Status

Enrolling

Conditions

Upper Extremity Amputee

Treatments

Device: iSens

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04430218
CDMRP-PR241366 (Other Identifier)
RX003355-01 (Other Grant/Funding Number)
HT94252510204 (Other Grant/Funding Number)
1612632 (Other Identifier)
A3355-R

Details and patient eligibility

About

The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.

Full description

The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.

Enrollment

15 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 21 or greater
  • Acquired upper limb amputation
  • Unilateral or bilateral amputation, Above or below elbow
  • At least 6 months since time of amputation
  • Current user of a myoelectric prosthesis or prescribed to use one
  • Viable target nerves in the upper extremity *
  • Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities

Exclusion criteria

  • A contraindication preventing surgery
  • Uncontrolled diabetes
  • Chronic skin ulcerations
  • History of poor wound healing without specific cause
  • History of uncontrolled infection without specific cause
  • Active infection
  • Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
  • Inability to speak English
  • Expectation that MRI will be required at any point for duration of study or while device is implanted.
  • Arthritis in the area of implant
  • Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
  • Presence of auto immune diseases, or conditions requiring immunosuppression.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

15 participants in 2 patient groups

iSens
Experimental group
Description:
3 months trial with the iSens system
Treatment:
Device: iSens
State of the Art Prosthesis
No Intervention group
Description:
3 months trial with their own prosthesis.

Trial contacts and locations

1

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Central trial contact

Melissa S Schmitt; Dustin J Tyler, PhD

Data sourced from clinicaltrials.gov

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